EXTEDO Provides its Solutions to Fresenius Kabi Enterprise-wide
Ottobrunn, Germany – June 2nd, 2009 – EXTEDO, a key services and solutions provider in the field of regulatory data and document management for Life Sciences industries and authorities, today announced, that Fresenius Kabi has rolled out EXTEDO products to its global organization.
Fresenius Kabi employs a range of EXTEDO products and solutions to streamline its business and to improve efficiency. eCTDmanager, EXTEDO’s scalable, ‘all-in-one’ electronic submission management system for both eCTD’s, and non-eCTD electronic and paper submissions, is integrated with IBM Score at Fresenius Kabi and has enabled Fresenius Kabi to prepare new drug applications and variations. “The tool is easy to use and the IT support from EXTEDO was both fast and straightforward. This was one major benefit for the important roll out of eCTDmanager to our global organization,” said Anthony Agidotan, Manager Regulatory Affairs at Fresenius Kabi.
After the implementation of the eCTD was finalized in the ICH region, Fresenius Kabi started looking for a suitable vendor that had developed a tool for eCTD regulatory submission publishing. EXTEDO’s eCTDmanager fulfilled all these requirements, and this tool was purchased by Fresenius Kabi in October 2007 and immediately installed. “We also selected EXTEDO’s DOCvalidator solution. This application reports formatting errors within both MS Word and PDF documents, and we successfully use it to validate the format of Fresenius Kabi templates and regulatory documents, thereby preventing a refuse to file,” added Mr. Agidotan. DOCvalidator, configured to your specific documentation standards, enables the verification of both legacy documents and externally created documents thereby ensuring the consistency and reliability of your documents.
Employing over 20,000 people worldwide and managing a global network of approximately 55 sales organizations and over 55 production sites, creating efficiencies and synergies across processes is critical to Fresenius Kabi’s success. “The EURS is Yours product, EXTEDO’s proprietary solution for eCTD validation and retrieval, helped us streamline many of our processes,” concludes Agidotan. “The software, easily installed and fully compatible with our existing information system, saved us time and money in meeting the requirements of the EMEA and National Competent Agencies.”
About Fresenius Kabi
Fresenius Kabi, a subsidiary of Fresenius SE, is the European market leader in infusion therapy and clinical nutrition. The company also holds a leading market position in both the Asia Pacific region and Latin America. In the US market Fresenius Kabi is a leading supplier of I.V. generic drugs. Therapy and care of chronically and critically ill patients, both inside and outside hospital, is a key focus of the company. Dedicated to improving patients’ quality of life, the company embodies its philosophy of “Caring for Life”.
About EXTEDO
For close to 15 years EXTEDO has been a key services and solutions provider in the field of regulatory data and document management for the Life Sciences industries and authorities (Pharmaceutical, Crop Science, Chemicals). Based on industry and regulatory expertise and many years of experience, EXTEDO provides highly standardized as well as customized solutions in the area of electronic Regulatory Affairs.
EXTEDO has designed and implemented the EURS system at EMEA and at various National Competent Authorities. EXTEDO maintains the open standard CADDY.xml for the electronic submission of Crop Sciences applications to support the mission of the ECPA.
Media Contact:
Andrea Beeker
Marketing
EXTEDO GmbH
contact
PR Fresenius Kabi